D-1008-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- November 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 799 cartons/1 bottle each
Product Description
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30
Reason for Recall
cGMP deviations: Temperature abuse
Distribution Pattern
USA nationwide.
Code Information
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.